8 [6.1] at start of continuation phase pharmacotherapy [n = 12] and 30.1 [6.1] at 6 months [n = 7]).

Figure 1 depicts individual participants’ patterns of change in the metabolic data between baseline and 6 months, after an overnight fast for glucose, triglyderides, cholesterol, HDL, and LDL. In general, values were stable over time. One person each had a spike in glucose, triglycerides, and cholesterol/LDL. After the 6-month follow-up, this last person was started on a statin prescribed by their primary care http://www.selleckchem.com/products/Vorinostat-saha.html physician, who judged that the benefit of continuing treatment with aripiprazole in the study was substantial, and that Inhibitors,research,lifescience,medical metabolic changes could be managed medically. Figure 1. Metabolic profile of individual patients (each selleck chem Pazopanib indicated by a separate symbol) during continuation treatment with aripiprazoie over a median period of 6 months. Inhibitors,research,lifescience,medical In general, glucose and triglycerides showed minimal change, suggesting that aripiprazole does not cause insulin resistance as do some other atypicals do (eg, olanzapine). In a comprehensive review of this topic, Newcomer Inhibitors,research,lifescience,medical showed that generally a lipid signal with atypicals will be seen in triglycerides; thus the lack of a signal in these pilot, data suggest that aripiprazole will be a safe treatment in older adults with respect, to metabolic effects.97 We plan to closely control the collection procedures in subjects, so that pre -post differences are not due to variability in fasting, stasis-venous

collection, etc. The lack of clinically informative data on this in the elderly is striking in light of the high cardiovascular mortality Inhibitors,research,lifescience,medical in mentally ill persons generally and underscores the need for this research.104 These data from acute and continuation

open pharmacotherapy illustrate three points. Further investigation should evaluate both the benefits and the costs (eg, adverse effects, metabolic changes) of adjunctive aripiprazole pharmacotherapy, using a double-blind, Inhibitors,research,lifescience,medical randomized, placebo-controlled design. These data show the feasibility and safety of treating participants (i) during acute-phase pharmacotherapy (n=24), to determine change from incomplete to complete response; and (ii) during continuation -phase pharmacotherapy (n=12), Batimastat to determine stability of remission and rates of depressive relapse. These data also underscore the importance of examining risks, as well as benefits, in a large randomized, double-blind, placebo-controlled study. The cost-benefit ratio and the ensuing clinical conclusions may be very different when benefit and harm are conjointly considered, from what they are when benefit, and harm are considered separately (as the post-marketing experience with COX-2 inhibitors and oral hypoglycemic agents teaches us, vis-à-vis heart disease). We believe that this is the most appropriate approach scientifically and ethically to a treatment study of frail older depressed patients who have responded only partially to antidepressant pharmacotherapy.